Process Development Engineer II

We anticipate the application window for this opening will close on - 11 Nov 2025

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

The Process Development Engineer II will support teams driving technology innovation with emphasis on improving quality, technical rigor and developing state-of-the-art mechanized and semi-automated systems.

At our Structural Heart & Aortic Advanced Manufacturing (AME) Engineering team in Santa Ana, Medtronic, plc, we focus designing and developing cutting-edge technologies for the manufacture of bioprosthetic heart valve in the Cardiovascular Portfolio. Our Engineers are directly involved in the development of innovative products and processes for use in medical procedures.

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We are working onsite a minimum of 4 days per week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. This role will require less than 10% of travel to enhance collaboration and ensure successful completion of projects.

As an engineer you will actively participate in all areas of new product development for bovine and porcine heart valves, including the following: Technology Development & Advancement, Process Development, Mechanization & Semi Automation, Vendor Management & Project Management.

Process Technologies : You will support teams driving technology innovation with emphasis on improving quality, technical rigor and developing state-of-the-art mechanized and semi-automated systems. Such activities include, but are not limited to, the following:

• Support feasibility or proof of principle studies that explore new process technologies and evaluate its potential for application to bioprosthetic heart valve manufacturing
• Analyze results and make recommendations
• Drive post-launch process improvements and cost-reduction initiatives through structured problem solving, collaboration with manufacturing sites, and leveraging automation or mechanization opportunities to enhance yield and reduce COGS

Process Development: You will use Design, Reliability & Manufacturability methodology (DRM), and 3-D drawing to develop best in class processes and manufacturing lines for the manufacture of our heart valve product ranges. Such activities include, but are not limited to, the following:

• Support process development, characterization, and validation (IQ, OQ, PQ) activities to support new product introduction
• Collaborate with cross-functional teams, primarily R&D, Operations and Quality, to define, execute, and deliver on New Product Development requirements
• Compile, document, and present all learnings to project and functional teams e.g., Technical Reviews, Design Reviews, Project Dashboards, process Development reports
• Participate in functional initiatives that support the continuous improvement of the Process Development organization.

Process Transfer : You will support activities that are required for transfer of pilot line/ developed processes during product development phase to commercial operations. Such activities include, but are not limited to, the following:

• Support the development and implementation of transfer plan activities; ensure pilot line transfer, process transfer, and/or process technology are implemented efficiently and effectively into commercial production or receiving site
• Generate and execute plans for equipment qualification and process validation; develop plans to evaluate process capability; support test method development and validation where needed
• Provide engineering support to manufacturing operation on routine basis; investigate and address product related issues arising on the pilot line and production line following process transfer
• Partner with cross-functional teams (Operations, Quality, and R&D) to assess and implement engineering solutions that enhance process capability, reduce variability, and strengthen product robustness throughout the lifecycle

Requirements

• Bachelor of Science Degree in a related engineering discipline (i.e., mechanical, biomedical, industrial, materials science)
• 2+ years in manufacturing environment and/or product/process development

Nice to Have

• Experience using statistical techniques and analysis
• Experience with designing tooling/fixture design and qualification
• Experience with Solidworks
• Experience working in and/or designing for a clean room environment
• Experience with cardiovascular and/or tissue-based products

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

Medtronic offers a competitive Salary and flexible Benefits Package

A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

Salary ranges for U.S (excl. PR) locations (USD):$80, $121,200.00This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance , Health Savings Account , Healthcare Flexible Spending Account , Life insurance, Long-term disability leave , Dependent daycare spending account , Tuition assistance/reimbursement , and Simple Steps (global well-being program).

The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match , Short-term disability , Paid time off , Paid holidays , Employee Stock Purchase Plan , Employee Assistance Program , Non-qualified Retirement Plan Supplement (subject to IRS earning minimums) , and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below:

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.

Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.

We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.